Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study)

BMC Psychiatry

Study Protocol

Luis Salvador-Carulla¹  Pilar LaFuente²  Carmen Montón-Franco³  Juan Ángel Bellón⁴  Jose Manuel Aranda-Regules⁵  María Isabel Ballesta-Rodríguez⁶  Juan Mendive⁷  Carlos Martín-Pérez⁸  Emiliano Rodríguez-Sánchez⁹  José María Aiarzaguena^1,10  Antonina Rodríguez-Bayón^1,11  Juan de Dios Luna^1,12  Alberto Rodriguez-Morejón^1,13  Irwin Nazareth^1,14  Luz Araujo^1,15  Patricia Moreno-Peral^1,15  Sonia Conejo-Cerón^1,15  Desirée Navas-Campaña^1,15  María del Mar Muñoz-García^1,15  Diego Palao^1,16  Michael King^1,17  Anna Fernández^1,18  Antoni Serrano-Blanco^1,18  Carmen Fernández-Alonso^1,19  Fernando Zubiaga^2,20  Maite Espinosa-Cifuentes^2,21  María Cruz Gómez^2,21  Pilar Mínguez-Gonzalo^2,22  Inmaculada Ibanez-Casas^2,23 

[1] Centre for Disability Research and Policy, Faculty of Health Sciences, University of Sydney, Sydney, Australia;Centro de Salud Andorra, Teruel, Instituto Aragonés de Ciencias de la Salud, Teruel, Zaragoza, Spain;Centro de Salud Casablanca. Instituto Aragonés de Ciencias de la Salud. IIS Aragón. Departamento de Medicina y Psiquiatría, Universidad de Zaragoza, Spain;Centro de Salud El Palo, Unidad de Investigación del Distrito de Atención Primaria de Málaga Departamento de Medicina Preventiva, Universidad de Málaga, Málaga, Spain;Departamento de Medicina Preventiva, Facultad de Medicina, Universidad de Málaga, Campus de Teatinos, 29071, Málaga, Spain;Centro de Salud El Torcal, Distrito Sanitario Málaga, Málaga, Spain;Centro de Salud Federico del Castillo, Jaén, Spain;Centro de Salud La Mina, Institut Català de la Salut, Barcelona, Spain;Centro de Salud Marquesado, Área Nordeste de Granada, Granada, Spain;Centro de Salud Miguel Armijo, Salamanca, Spain;Centro de Salud San Ignacio, Unidad de Investigación de Atención Primaria, Osakidetza, Bilbao, Spain;Centro de Salud San José, Linares, Jaén, Spain;Departamento de Bioestadística, Universidad de Granada, Granada, Spain;Departamento de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Málaga, Málaga, Spain;Department of Primary Care and Population Health, UCL, London, UK;Fundación IMABIS, Unidad de Investigación del Distrito de Atención Primaria de Málaga, Málaga, Spain;Hospital Parc Taulí, Servei de Salut Mental, Sabadell, Barcelona, Spain;Mental Health Sciences, Faculty of Brain Sciences, UCL, London, UK;Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, Barcelona, Spain;Servicio de Programas Asistenciales, Gerencia Regional de Salud, Valladolid, Spain;Unidad de Investigación de Atención Primaria, Centro de Salud Arrabal, Zaragoza, Spain;Unidad de Investigación de Atención Primaria, Osakidetza, Bilbao, Spain;Unidad de Investigación de Atención Primaria, Valladolid, Spain;“Centro de Investigación Biomédica en Red de Salud Mental” CIBERSAM, Universidad de Granada, Granada, Spain;

关键词: Depression;    Primary prevention;    Primary health care;    Randomized controlled trial;   

DOI  :  10.1186/1471-244X-13-171

 received in 2013-05-09, accepted in 2013-05-29,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundThe ‘predictD algorithm’ provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression.Methods/DesignThis is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system.DiscussionTo our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations.Trial registrationClinicalTrials.gov identifier: NCT01151982

【 授权许可】

CC BY   
© Bellón et al.; licensee BioMed Central Ltd. 2013